Drug Development Strategy
Viglya helps clients develop regulatory strategies that focus on discovering and rapidly building scientific evidence to support the safety and efficacy of compounds. We assist in identifying and addressing critical path issues that could delay development timelines, and we help define the hurdles to registration. We provide strategic guidance in marketing authorization applications (MAAs), clinical (efficacy and safety) summaries, overviews, and labeling development.
Viglya also assists with legal representation activities in Europe and provides full United States (U.S.) Agent services, including U.S. Investigational New Drug (IND) submission, negotiation, and maintenance.
- Strategic development and execution of comprehensive drug development programs based on the compound’s Target Product Profile and the regulatory landscape.
- Strategic input in U.S. FDA meeting planning (pre-IND/IND, end-of-Phase I, II, III, and pre-New Drug Application (NDA) meetings); briefing documents preparation and review.
- Guidance in the preparation for European scientific advice (including European Medicines Agency [EMA] and national procedures): briefing documents preparation and review.
- Clinical Trial Application (CTA) and U.S. IND preparation, review and filing.
- Guidance in contract research organization (CRO) selection for individual clinical trials and for full clinical programs execution (CRO qualification and selection, Services Agreement review).
- CRO oversight (communication plans with milestone identification, technical plans, governance model).
- Preparation of presentations for Investigator Meetings and Scientific Advisory Boards.
- Review of charters for Data Safety Monitoring Boards, Adjudication Committees, Steering Committees (clinical programs). Participation in presentation generation and delivery.
- Assistance with drug registration processes both in the U.S. and in Europe:
- Integrated Summary of Safety (ISE/ISS);
- Integrated Summary of Effectiveness (CSE/CSS);
- Clinical Overview.
- Risk Evaluation and Mitigation Strategies (REMS) and Risk Management Programs (RMPs).
- Development of initial U.S. Package Insert, European Summary of Product Characteristics (SPC), patient leaflet and other local product information documents based on data from product development, the most current labeling guidelines and regulations, product therapeutic areas, recent approvals, and regulatory trends.
- Assistance in due diligence activities (European Union, U.S.) for products in all phases of development and commercialization: Conduct of independent data assessment;
Assessment of the level of regulatory risk (serious non-compliance).
- Assistance in identification of opportunities for in-licensing and out-licensing.
- Identification of business partners for critical business functions, such as drug development, distribution, and co-marketing.